A Pivotal, Prospective, Open-label, Multi-center Study of Safety and Effectiveness of Cochlear Implantation in an Expanded Population of Adults With Bilateral Sensorineural Hearing Loss
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Cochlear
- 入组人数
- 50
- 试验地点
- 13
- 主要终点
- Mean change on aided word recognition in the unilateral CI alone listening condition at 6 months post-activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted
研究概览
简要总结
This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals 18 or older at the time of consent
- •Meets the following audiometric criteria for the ear to be implanted: clinically established sensorineural hearing loss (SNHL) defined by a four frequency pure tone average (PTA) at 500, 1000, 2000, & 4000 Hz of: ≥60 dB HL and compromised functional hearing in the aided condition defined as <50% correct on a word recognition test
- •Meets the following audiometric criteria for the non-implanted contralateral ear: clinically established SNHL defined by a four frequency PTA at 500, 1000, 2000, & 4000 Hz of >30 dB HL
- •Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator.
- •Willing and able to provide written informed consent.
排除标准
- •Meets current indications on audiometric thresholds for traditional adult CI candidates (i.e., bilateral moderate to profound hearing loss in the low frequencies and profound [≥ 90 dB HL] hearing loss in the mid to high speech frequencies)
- •Absence of cochlea development or a cochlear nerve
- •Presence of active middle ear infection in the ear to be implanted
- •Tympanic membrane perforation in the presence of active middle ear disease in the ear to be implanted
- •Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation.
- •Existing contralateral cochlear implant or medical plan to implant a contralateral cochlear implant during the clinical investigation.
- •Pregnant or breastfeeding women. Women who plan to become pregnant during the course of the clinical investigation.
- •Unrealistic expectations on the part of the participant, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the investigator.
- •Additional disabilities that may affect the participant's participation of safety during the clinical investigation.
- •Unable or unwilling to comply with all of the requirements of the clinical investigation as determined by the investigator.
- •Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- •Employees of Cochlear.
- •Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation.
研究组 & 干预措施
Cochlear™ Nucleus® System
Participants will be implanted with a commercially approved Cochlear™ Nucleus® implant.
干预措施: Cochlear™ Nucleus® System (Device)
结局指标
主要结局
Mean change on aided word recognition in the unilateral CI alone listening condition at 6 months post-activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted
时间窗: Pre-operative baseline, 6 months post-activation
The CNC word recognition test (for English speakers) and Spanish Bisyllabic word test (for Spanish speakers) will be administered in quiet at a level equal to 60dBA in the sound field. The tests will be scored as total number of words correct, which will be expressed as a percentage correct for this study.
Number of device and procedure-related adverse events and serious adverse events
时间窗: 6-months post-activation
Events will be summarized by type, frequency, and severity.
Mean change on AzBio sentences in noise at 6 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition
时间窗: Pre-operative baseline, 6 months post-activation
The AzBio sentence test (for English speakers) and the Spanish AzBio sentence test (for Spanish speakers) will be utilised. These are validated tests to assess the open-set sentence recognition in quiet or in the presence of competing noise. For this study, the target sentences will be presented at a fixed level of 65dBA starting at a +10 dB signal-to-noise ratio using multi-talker babble as the competing signal. Each word in the sentence counts towards the overall score, which will be expressed as a percent correct for this study.
次要结局
- Percentage correct on AzBio sentences in noise in the post-operative everyday listening condition(6 months post-activation)
- Proportion of participants who demonstrate a change score of +1 or greater on the Speech, Spatial and Qualities of Hearing Scale (SSQ12) at 6-months post-activation compared to preoperative baseline(Pre-operative baseline, 6 months post-activation)
- Mean change on the Tinnitus Handicap Inventory (THI) score at 6-months post-activation compared to preoperative baseline will exceed a 7-point improvement(Pre-operative baseline, 6 months post-activation)
- Number of device and procedure related adverse events and serious adverse events(36-Months post-activation)
- Mean change on aided word recognition in the unilateral CI alone listening condition at 3 months post activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted(Pre-operative baseline, 3 months post-activation)
- Mean change on AzBio sentences in noise at 3 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition(Pre-operative baseline, 3 months post-activation)
- Percentage correct on aided word recognition in the unilateral condition in the implanted ear in the post-operative everyday listening condition(6 months post-activation)